From the Editor

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From the Editor: Medical

In the spirit of promoting public transparency, the U.S. Food and Drug Administration’s Center for Devices and Radiological Health is taking a number of...

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From the Editor: Medical

Political uncertainty will be the biggest factor that could upend healthcare transactions according to a recent Merrill InsightTM poll of global mergers and...

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From the Editor: Design

A new house bill is set to end the medical device tax once and for all. H.R. 2207 was introduced in April — it’s goal to permanently repeal the...

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From the Editor: Medical

Spurring Innovation of Brain-Computer Interface Devices FDA is continuing to encourage innovation in novel areas — the latest being novel brain implants, often...

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From the Editor: Wearables

When digital devices and technologies became the rule rather than the exception, FDA had to rethink its regulatory framework and evaluation process...

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From the Editor: Connectivity

Making changes to a regulatory process is usually difficult, slow, and often painful — after all, it involves lots of bureaucracy and many “cooks in the kitchen.” But...

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From the Editor: Internet of Things

The IoMT has ushered in a new era for connected medical technology. But battery life is often mentioned as one of the impediments to the...

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From the Editor: Medical

With a 2020 deadline looming for the European Union’s Medical Device Regulation (MDR), medical device makers “lack understanding of the new rules...

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From the Editor: Software

In September, FDA granted de novo classification to two apps offered in the new Apple Watch Series 4, which the tech giant says have been “redesigned and...

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From the Editor: Regulations/Standards

Earlier this year, FDA sent a challenge to the medical device industry: develop devices and diagnostics to help combat, prevent, and treat the opioid...

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From the Editor: Medical

New research has confirmed what device companies have been saying since the medical device excise tax was imposed on medical devices as part of the Affordable Care...

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From the Editor: AR/AI

The medical device industry’s active M&A market and uncrowded investment space make it attractive for investors looking to...

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From the Editor: Medical

I am truly excited about this month’s inaugural MedInnovation conference. It’s goal is to present a roadmap for getting innovative — and by that, I mean game...

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From the Editor: Medical

A virtual reality system for training surgeons is gaining traction with major medical device companies looking to mitigate misuse and liability...

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From the Editor: Medical

A new interactive conference will address key strategies for the commercialization of emerging medical technologies, and its unique...

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From the Editor: Motion Control

In December, we asked Medical Design Briefs readers to cast their ballot to choose from our 12 Products of the Month the technology they felt was the most significant new introduction to the design...

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From the Editor: Manufacturing & Prototyping

FDA is monitoring the emerging field of 3D printing and additive manufacturing, an area FDA once considered a “futuristic technology on the distant...

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From the Editor: Sensors/Data Acquisition

The integration of robotics into medical devices has seen explosive growth in recent years with new applications in areas such as prosthetics and...

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From the Editor: Medical

FDA has qualified the first tool under its new Medical Device Development Tool (MDDT) program. According to AAMI, after some 20 years of use, manufacturers of devices...

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From the Editor: Medical

In this world of increasingly smart technology, the one place that interconnectivity is critical is in healthcare. Patients and their care givers should be confident that the...

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From the Editor: Medical

The Future of Medical Manufacturing implementing automation. It is embracing 3D printing, Industry 4.0, the Internet of Things, artificial intelligence (AI), and even augmented reality...

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From the Editor: Medical
Medtech M&A on the Rise Again

It appears that the medtech industry has responded to a healthier market by going on a shopping spree. According to EP Vantage, a service of market analysis firm Evaluate, medtech mergers are back. EP says that the sum spent on deals in the first half of 2017 has already surpassed last year’s total, “putting...

From the Editor: Medical
MedAccred Makes Its Mark

The industry was buzzing when Stryker announced in July that it would require its future suppliers of critical manufacturing processes to be accredited by MedAccred, a medical supply chain oversight program formed in 2010 by the Performance Review Institute.

From the Editor: Connectivity
Your Cyberattack Wake-Up Call

We’ve been hacked. Forbes reports that the WannaCry ransomware did, in fact, infect a Bayer Medrad radiology power injector in U.S. hospitals. Thankfully, no safety-related functions were affected directly, but what about next time?

From the Editor: Internet of Things
The Internet of Dangerous Things

“The dangerous world we live in is one where the embedded systems that we build are increasingly a battlefield, a place where anonymous hackers are able to remotely injure and potentially kill people on the other side of the world because dangerous devices are connected to the Internet.” Barr Group CTO...

From the Editor: Regulations/Standards
Permanent Device Tax Repeal Is ‘Highest Priority’

Incoming AdvaMed chairman Nadim Yared will continue AdvaMed’s drive to ensure a permanent repeal of the medical device excise tax, calling it his “highest priority” heading into his term as chairman. Yared, who is president and CEO of CVRx, spoke at a press conference in April.

From the Editor: Medical
Confidence High, but Concerns Remain

A recent forecast indicates a mostly positive outlook for the international medtech industry but highlights a few areas that will present challenges going forward. The “8th Thinking Ahead! LIMEDex Index Report” was authored by Beatus Hofrichter, found - er and managing partner of conceplus, a medtech...

From the Editor: Manufacturing & Prototyping
And the Winners Are...

In December, we asked Medical Design Briefs readers to cast their ballot to choose from our 12 Products of the Month the technology they felt was the most significant new introduction to the design engineering community in 2016. The selected products reflect advances that enable new innovations in medical technology. Here...

From the Editor: Medical

As 2016 came to a close, the U.S. House of Representatives overwhelmingly approved the 21st Century Cures Act by a vote of 392–26, and the Senate passed it by a vote of...

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Ask the Expert

Eric Dietsch on the Benefits of Nitinol Wire
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In collaboration with the Fort Wayne Metals Engineering team, Eric Dietsch focuses on supporting customers with material recommendations, product development, and education. Eric is available to help you and your company with any Nitinol-related questions or needs that you may have.

Inside Story

Inside Story: Validating Your Sterilization Process
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To find out more about sterile product development and registration, MDB recently spoke with Elizabeth Sydnor, Director of Microbiology of Eurofins Medical Device Testing (Lancaster, PA). Read the interview.

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